Action To promote brain Health iN Adults (ATHENA): a pilot feasibility trial
There is considerable randomised evidence to support lowering blood pressure (BP) to reduce the risk of cognitive decline and dementia.
Hypertension, coupled with other risk factors such as high cholesterol, obesity, diabetes and a family history of dementia, are recognised as key risk factors for dementia and cognitive decline from mid-life onwards. The current 2020 COVID-19 pandemic has challenged the undertaking of face-to-face visits for research studies and inevitably limits study recruitment opportunities. Recent studies have therefore supported the validity and reliability of administering videoconference-based neuropsychological tests in rural and urban settings as an alternative to traditional face-to-face testing.
ATHENA will evaluate the tolerability, safety and adherence of a risk reduction approach in a high-risk target population, evaluating a BP lowering low-dose triple pill or placebo intervention. It will also test the feasibility of recruitment and assessment of a population with higher-than-average risk of dementia, by asking participants to complete neuropsychological assessments via videoconference, CogState brief battery’s independently online, and monitor their own BP at home.
ATHENA is an investigator-initiated and conducted, double-blind, placebo-controlled, randomised controlled pilot trial that will involve 50 participants at risk for dementia recruited from the community in New South Wales, Australia. Randomised participants will receive study medication for 4 weeks, and all the visits will be conducted remotely.
As a pilot feasibility trial, the ATHENA study will help us determine if the remote conduct of clinical trials in this population group (adults between 50-70 years) can be successful. Lessons learnt during the ATHENA trial will allow us to improve the delivery of remote trials, and widen the scope of recruitment in clinical trials in the future.
• Approximately 40% of Australian’s aged between 50 and 70 years have moderately elevated blood pressure, which is a known risk factor for dementia.
• As there are no available medications that can prevent dementia, reducing dementia risk factors, like high blood pressure, is a promising approach.
• Dementia pathology is likely to begin 20-30 years before diagnosis, so late mid-life (ages 50-70) is a critical period for risk reduction.
• To be successful, blood pressure lowering treatment would need to be both very safe, and taken for many years.
We are now recruiting participants who would be interested in participating in this trial. Those interested may refer to the Participant Information Sheet & Consent Forms on this page and visit https://athenastudy.georgeinstitute.org/ for more information. You can get in touch with us:
Ph: 02 8052 4652
This study, in collaboration with UNSW Sydney and The Brain and Mind Centre of The University of Sydney, is supported by Program Grant APP1149987 (2019-2023) from the National Health and Medical Research Council (NHMRC) of Australia